Clinical Biomarker Specimen Specialist

🔥 15 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Manage clinical specimens from collection through testing and final disposition • Ensure compliance with clinical protocol and informed consent • Maintain chain of custody • Organize and oversee collection, shipping, storage, and maintenance of clinical specimens • Resolve and/or triage specimen queries from sites or vendors • Obtain and appropriately file documentation of specimen destructions • Collaborate on implementation and maintenance of the specimen tracking system • Work with Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, and Data Management to align and execute specimen management at the study level • Ensure timely and smooth collection, transfer, and testing of clinical trial specimens

🎯 Requirements

• 2–5 years of experience, dependent on level of related skills and education • Laboratory background and/or strong knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays • Effective project management and time management skills; able to prioritize successfully • Proficiency with data sets and Excel, understanding of data relationships and metadata • Experience overseeing vendors and communicating with experts to drive quality deliverables • Technologically savvy; able to quickly pick up new information, standards, regulations, tools, methods, or software • Detail oriented; performs quality and accurate work with minimal oversight • Excellent written and verbal communication skills • Organizational skills and ability to identify efficiency improvements and appropriate resources for deliverables • Interpersonal skills; encourages collaboration and builds constructive relationships • Flexible, adaptable, and capable of problem-solving • Able to learn new skills, offer new ideas, and adapt to existing processes • Preferred: previous biobanking, sample tracking, and handling experience • Preferred: previous LIMS experience • Preferred: working knowledge of the clinical drug development process • Preferred: working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, and UAT • Preferred: oncology experience and/or working knowledge • Preferred: proficiency with timeline management • BA/BS in a relevant field; years of experience may substitute for education

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